Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).
Official title: A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
743
Start Date
2021-08-19
Completion Date
2036-09-22
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Bortezomib
Bortezomib will be administered SC.
Dexamethasone
Dexamethasone will be administered orally.
Lenalidomide
Lenalidomide will be administered orally.
Cilta-cel
Cilta-cel infusion will be administered.
Cyclophosphamide
Cyclophosphamide will be administered intravenously.
Fludarabine
Fludarabine will be administered intravenously.
Locations (136)
UCSF
San Francisco, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Miami Health System
Miami, Florida, United States
AdventHealth Cancer Institute
Orlando, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
University Of Maryland Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Presbyterian-Weill Cornell Medical College
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Aleman
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital Privado Universitario De Cordoba
Córdoba, Argentina
Royal Prince Alfred Hospital
Camperdown, Australia
St Vincents Hospital Melbourne
Fitzroy, Australia
Austin Health
Heidelberg, Australia
Royal Brisbane and Womens Hospital
Herston, Australia
Alfred Health
Melbourne, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
Fiona Stanley Hospital
Murdoch, Australia
Calvary Mater Newcastle Hospital
Waratah, Australia
Western Sydney Local Health District
Westmead, Australia
Medizinische Universitat Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie
Graz, Austria
Krankenhaus der Elisabethinen Linz
Linz, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria
Medical University of Vienna Universitatsklinik fur Innere Medizin I
Vienna, Austria
Universitair Ziekenhuis - Antwerpen
Antwerp, Belgium
AZ St.-Jan Brugge-Oostende AV
Bruges, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, Belgium
Hospital Sao Rafael
Salvador, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni Nemocnice Ostrava
Ostrava - Poruba, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Aarhus University Hospital
Aarhus N, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense Universitetshospital
Odense C, Denmark
Helsinki University Hospital
Helsinki, Finland
Oulu University Hospital
Oulu, Finland
Turku University Hospital
Turku, Finland
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
Lille, France
C.H.U. Hotel Dieu - France
Nantes, France
Hopital Saint Louis
Paris, France
CHU Poitiers - Hopital la Miletrie
Poitiers, France
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse, France
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, Germany
Klinikum Großhadern der Ludwig-Maximilians-Universität
München, Germany
Universitaetsklinikum Regensburg
Regensburg, Germany
Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
Tübingen, Germany
Universitatsklinikum Wurzburg
Würzburg, Germany
Alexandra General Hospital of Athens
Athens, Greece
Attikon University General Hospital of Attica
Athens, Greece
G.Papanikolaou
Thessaloniki, Greece
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
St James Hospital
Dublin, Ireland
Hadassah University Hospita Ein Kerem
Jerusalem, Israel
Sheba Medical Center Tel Hashomer
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Juntendo University Hospital
Bunkyō City, Japan
Kyushu University Hospital
Fukuoka, Japan
Hyogo Medical University Hospital
Hyôgo, Japan
Kanazawa University Hospital
Kanazawa, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan
Nagoya City University Hospital
Nagoya, Japan
Okayama University Hospital
Okayama, Japan
Hokkaido University Hospital
Sapporo, Japan
Tohoku University Hospital
Sendai, Japan
Japanese Red Cross Medical Center
Shibuya City, Japan
VU Medisch Centrum
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
UMC Radboud
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
Oslo universitetssykehus HF, Rikshospitalet
Oslo, Norway
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
Gliwice, Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Poland
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, Portugal
Chonnam National University Hwasun Hospital
Jeollanam-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea
Hosp. de La Santa Creu I Sant Pau
Barcelona, Spain
Hosp Univ Vall D Hebron
Barcelona, Spain
Instituto Catalan Deoncologia Hospital Duran I Reynals
L'Hospitalet de Llobregat, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp. Univ. Virgen de La Arrixaca
Murcia, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Hosp Clinico Univ de Salamanca
Salamanca, Spain
Hosp. Univ. Marques de Valdecilla
Santander, Spain
Hosp. Virgen Del Rocio
Seville, Spain
Hosp. Univ. I Politecni La Fe
Valencia, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
Universitetssjukhuset
Linköping, Sweden
Skane University Hospital
Lund, Sweden
Universitatsspital Basel
Basel, Switzerland
Inselspital Universitatsspital Bern
Bern, Switzerland
Kantonsspital St Gallen
Sankt Gallen, Switzerland
University Hospitals Birmingham NHS Trust,
Birmingham, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
University College Hospital
London, United Kingdom
Kings College Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
The Royal Marsden NHS Trust Sutton
Surrey, United Kingdom